Researchers Are About to Launch the Largest AIDS Treatment Trial EverBiopharmaDive
By Nicole Gray
July 20, 2015

Researchers at University of California at San Francisco (UCSF) are planning a 100-patient trial that determines whether very early treatment of HIV infection, followed by an interruption, can lead to a functional cure.

One basis for the trial is the example of a French teenager, who was treated aggressively from infancy to age six, and then received no treatment for 12 years. Despite the lack of treatment, she is considered "functionally cured," because the virus is lying dormant and does not require therapy to keep it under control.

The larger goal is to see if early treatment can make lifelong treatment unncecessary, even if an HIV-infected individual still has detectable levels of virus.

In the 1980s, the goal was to simply keep patients alive; however, gradually as drug cocktails containing different types of antiretroviral therapy (ART) became the standard of care, HIV became a condition that was not necessarily fatal in and of itself---but required lifelong therapy, including switching medications when the virus became resistant to whatever treatment was being used.

Scientists now have a new vision based on examples of patients who have experienced functional cures, including the young woman in France. Currently, Viiv Healthcare is working on a once-a-month HIV treatment, while NIH researchers are working on an immunotherapy approach to treating HIV and Gilead is already in early clinical trials to evaluate a drug, which flushes our hidden reservoirs of HIV. The goal of this therapy is a definitive cure.

In terms of the $5 million trial to evaluate the ability to functionally cure HIV, the researchers at UCSF will track patients who receive aggressive therapy early on post-infection and are then taken off of therapy. Patients will be monitored closely and put back on medication at the first sign of viral resurgence. Results could be available as soon as 2018.